Laparoscopic ColectomyNCT05268900
Ventilation Modes Effect on Intracranial Pressure During Laparoscopic Colectomy by Optic Nerve Sheath Diameter
A study of Laparoscopic Colectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Laparoscopic Colectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index less than 30
- American Society of Anesthesiologist physical class I -III.
Who cannot join
- Patient refusal
- operative time < 2 hour (h)
- Patients with preexisting eye disease.
- History of eye surgery
- Optic nerve disease.
- Causes of elevated ICP.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University
Al Mansurah, DK, 050
Hanaa M El Bendary, MD, 00201005781768, Hanaa_elbendary@yahoo.com
Doaa G Diab, MD, 00201069507088, Basmalg@yahoo.com
About this study
Official title: Effect of Different Ventilation Modes on Intracranial Pressure During Laparoscopic Colectomy Guided by Optic Nerve Sheath Diameter Measurement.
Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.
Read the detailed description
The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,
- Conditions
- Laparoscopic Colectomy
- Being tested
- Volume control ventilation group, Pressure control ventilation-volume guaranteed group
- Keywords
- ventilation; intracranial pressure; laparoscopy
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume control ventilation groupDevice
Volume control ventilation mode
Pressure control ventilation-volume guaranteed groupDevice
Pressure control ventilation-volume guaranteed mode
| Study group | Role | What they receive |
|---|---|---|
| Volume control ventilation group | Placebo comparator | Patients' lungs will be ventilated with volume control ventilation mode Receives: Device: Volume control ventilation group |
| Pressure control ventilation-volume guaranteed group | Active comparator | patients' lungs will be ventilated with Pressure control ventilation-volume guaranteed mode Receives: Device: Pressure control ventilation-volume guaranteed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)
ONSD is the acronym of O(optic) N(nerve) S(sheath) D(diameter), that ONSD is a non invasive method for measurement of intracranial pressure The optimal cutoff value has not been established, they vary between 4.85 and 5.9 mm and >5.9 mm is a sure sign of increased intracranial tension
Measured: Changes from baseline, till 30 minutes after recovery from anaesthesia
Secondary outcomes (12)
Heart rate
is allowed to swing within 20% of the basal value
Measured: Changes from baseline, till 30 minutes after recovery from anaesthesia
Mean arterial blood pressure
is allowed to swing within 20% of the basal value
Measured: Changes from baseline, till 30 minutes after recovery from anaesthesia
Peak airway pressure
Peak airway pressure values should not exceed 30 cm H2O. Values greater than 40 cm H2O may be harmful to the normal lung. Peak pressure applies when there is airflow in the circuit, i.e.the maximum pressure during inspiration . What determines the peak pressure is the airway resistance in the lungs. So if there is a problem with the airways the peak pressure will rise.
Measured: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Plateau airway pressure
Plateau pressure is the pressure applied to small airways and alveoli during positive-pressure mechanical ventilation.when there is no air flow in the circuit. That is when inspiration is complete. This pressure is determined by the lung compliance. So it follows that if there is a problem with the compliance the plateau pressure will rise.
Plateau pressure is measured during an inspiratory pause on the mechanical ventilator.
Pplat is never bigger than PIP and is typically <10 cm H2O lower than PIP when airway resistance is not elevated.
Measured: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
mean airway pressure
mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma
Measured: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Dynamic Lung compliance
dynamic lung compliance Cdyn = VT / (PIP - PEEP)…..change in volume/change in pressure, where airflow resistance becomes a factor. which ranges physiologically in adults between 50 - 80 ml/cm H2O while for intubated, mechanically ventilated adults is about 30 to 40 ml/cm H2O
Measured: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Static Lung compliance
static compliance and dynamic compliance static lung compliance....Cstat = VT/ ( Pplat - PEEP) ….change in volume/change in pressure when there is no air flow..... The physiological Cstat for adult is 70 - 100 while for intubated, mechanically ventilated adults is about 50 to 60 ml/cm H2O
Measured: intra-operative changes from (post induction) just after induction of anesthesia and intubation, till the end of surgery (before extubation).
pH
PH ranges normally between 7.35 - 7.45 when >7.45 it is alkalosis when <7.35 it is acidosis
Measured: Changes from baseline, till 30 min after recovery from anesthesia.
PaCO2 (carbon dioxide tension)
PaCo2 which ranges normally between 35 -45 mmHg it increase above 45 with causes of hypercapnia as hypoventilation and insufflation with Co2 and decrease below 35 with hypotension, hypo-perfusion and excessive hyperventilation Normal PaCO2-EtCO2 difference is 2-5 mmHg
Measured: Changes from baseline, till 30 min after recovery from anesthesia.
Headache
the severity of headache will be recorded using visual analogue score (where 0 = no pain and 10 = worst pain imaginable), mild headache pain will be defined by scores 1-4, moderate; by scores 5-7, and severe; by scores 8-10.
Measured: for 24 hour after surgery
Postoperative nausea and vomiting
Nausea will be explained to all patients, where ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms ) and also the incidence of vomiting will be recorded by asking a questionnaire to all patients; is vomiting present or absent.
Measured: for 24 hour after surgery
PaO2 (partial pressure of arterial oxygen)
PaO2 should= FiO2 x 500 (e.g. 0.21 x 500 = 105 mmHg)
Measured: Changes from baseline, till 30 min after recovery from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic ColectomyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanaa M El Bendary, Study director, Assistant professor, MD anesthesia Department, Faculty of Medicine,Doaa G Diab, Study chair, professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268900
- Sponsor's protocol ID
- MD/ 21.10.553
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Ventilation Modes on Intracranial Pressure During Laparoscopic Colectomy Guided by Optic Nerve Sheath Diameter Measurement.
- ClinicalTrials.gov ID
- NCT05268900
- Acronym / sponsor ID
- MD/ 21.10.553
- Conditions
- Laparoscopic Colectomy
- Keywords
- ventilation; intracranial pressure; laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.
Detailed description
The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volume control ventilation group | Placebo comparator | Device: Volume control ventilation groupPatients' lungs will be ventilated with volume control ventilation mode |
| Pressure control ventilation-volume guaranteed group | Active comparator | Device: Pressure control ventilation-volume guaranteed grouppatients' lungs will be ventilated with Pressure control ventilation-volume guaranteed mode |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index less than 30
- American Society of Anesthesiologist physical class I -III.
Key exclusion criteria (6 listed)
- Patient refusal
- operative time < 2 hour (h)
- Patients with preexisting eye disease.
- History of eye surgery
- Optic nerve disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume control ventilation groupVolume control ventilation mode | Device | Volume control ventilation group |
| Pressure control ventilation-volume guaranteed groupPressure control ventilation-volume guaranteed mode | Device | Pressure control ventilation-volume guaranteed group |
Primary outcome
Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)
Time frame: Changes from baseline, till 30 minutes after recovery from anaesthesia
ONSD is the acronym of O(optic) N(nerve) S(sheath) D(diameter), that ONSD is a non invasive method for measurement of intracranial pressure The optimal cutoff value has not been established, they vary between 4.85 and 5.9 mm and >5.9 mm is a sure sign of increased intracranial tension
12 secondary outcomes
Heart rate
Time frame: Changes from baseline, till 30 minutes after recovery from anaesthesia
Mean arterial blood pressure
Time frame: Changes from baseline, till 30 minutes after recovery from anaesthesia
Peak airway pressure
Time frame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Plateau airway pressure
Time frame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
mean airway pressure
Time frame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Dynamic Lung compliance
Time frame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Static Lung compliance
Time frame: intra-operative changes from (post induction) just after induction of anesthesia and intubation, till the end of surgery (before extubation).
pH
Time frame: Changes from baseline, till 30 min after recovery from anesthesia.
PaCO2 (carbon dioxide tension)
Time frame: Changes from baseline, till 30 min after recovery from anesthesia.
Headache
Time frame: for 24 hour after surgery
Postoperative nausea and vomiting
Time frame: for 24 hour after surgery
PaO2 (partial pressure of arterial oxygen)
Time frame: Changes from baseline, till 30 min after recovery from anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanaa M El Bendary study director
Assistant professor, MD anesthesia Department, Faculty of Medicine,
Doaa G Diab study chair
professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Laparoscopic Colectomy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanaa M El Bendary (00201005781768, Hanaa_elbendary@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter) (time frame: Changes from baseline, till 30 minutes after recovery from anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.